Apparatus for treating excess intraocular fluid having an elastic membrane

ABSTRACT

A device ( 100 ) is provided for treating diseases that produce elevated intraocular pressures, such as glaucoma, wherein the device ( 100 ) includes a housing shell ( 101 ) defining a cavity ( 107 ) between a first end ( 102 ) and a second end ( 104 ) of the housing shell ( 101 ), and an elastic membrane ( 110 ) disposed within the cavity ( 107 ) to divide the cavity ( 107 ) into a fluidic channel ( 106 ) that permits a flow of fluid from the first end ( 102 ) to the second ( 104 ) end and a sealed cavity ( 112 ). The elastic membrane ( 110 ) deforms to change the volume of the sealed cavity ( 107 ) responsive to pressure fluctuations between the first and second ends ( 102, 104 ), thereby varying the fluidic resistance of the flow of fluid through the fluidic channel ( 106 ).

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to U.S. Provisional Patent ApplicationNo. 62/728,022, filed Sep. 6, 2018, the entire contents of which areincorporated herein by reference. This application is also related toU.S. patent application Ser. No. 15/612,988, filed Jun. 2, 2017, whichclaims the benefit of priority of U.S. Provisional Application No.62/346,456, filed Jun. 6, 2016, the entire contents of each of which areincorporated herein by reference.

FIELD OF INVENTION

This application relates to an apparatus for draining excess intraocularfluid to relieve intraocular pressure, for example, for treatingglaucoma.

BACKGROUND OF THE INVENTION

Glaucoma affects about 70 million people worldwide, and is a disorderassociated with high pressure in the eye resulting from the generationof excess intraocular fluid (aqueous humor). Aqueous humor is producedat a rate of 2-3 μl/min by the ciliary body and in a normal human eyemaintains a constant intraocular pressure (“IOP”) around 12-20 mmHgAqueous humor exits the eye primarily through the trabecular meshworkand Schlemm's canal, where it eventually drains to the episcleral veins.Maintaining intraocular pressure within appropriate ranges is criticalto health of the eye, and depends on aqueous humor dynamics, namely theproduction rate from the ciliary body (aqueous humor inflow) and itsoutflow rate through the trabeculum. The most frequent type of glaucoma,called open-angle glaucoma, results from an increase in the fluidicresistance of the trabecular meshwork. Left untreated, this diseasetypically causes damage to the optic nerve, with consequent loss ofvision, initially peripheral, but progressively leading to totalblindness. Unfortunately, glaucoma is often asymptomatic until late inthe progress of the disease.

Traditionally, glaucoma is treated using medication, for example, thedaily application of eye drops, such as Brinzolamide ophthalmic, thatreduce production of aqueous humor. Such medications do not cureglaucoma, and must be continue to be taken to maintain intraocularpressures within accepted limits. In certain cases, such treatment mayfail and other surgical treatments are employed, such as filterprocedures or placement of a glaucoma drainage device. Glaucoma drainagedevices reduce intraocular fluid pressure by providing an artificialdrainage pathway, thus maintaining a low IOP.

Previously-known glaucoma drainage devices usually comprise a structurehaving a drainage tube that is inserted through a small incision made inthe conjunctiva. The surgeon makes a tiny incision in the sclera of theeye and creates an opening for the drainage implant device. The drainagetube is placed such that the opening of the tube is disposed in theanterior chamber of the eye within the aqueous humor. The tube issutured in place with the drainage device attached to the sclera of theeye. Many surgeons will place an absorbable suture around the tube atthe time of surgery to prevent over-filtration through the device untila fibrous capsule has formed. Accordingly, such devices typically arenot functional until about 3 to 8 weeks after the procedure, so as toprevent over-filtration.

An exemplary previously-known passive glaucoma drainage device isdescribed in U.S. Pat. No. 4,457,757 to Molteno. The device described inthat patent comprises a tube of a biologically inert silicone configuredto be inserted into the eye to drain aqueous humor from the anteriorchamber of the eye. The device does not include a pressure regulatingmechanism, but instead relies on the resistance to aqueous flow throughthe tubing to prevent over drainage.

One drawback of devices such as those described in the Molteno patent isthat the drainage flow depends on IOP and on the fixed hydrodynamicresistance of the shunt. In many cases, however, the hydrodynamicresistance of the shunt may not be sufficient to reduce high IOP whenthe resistance to flow is too high, or may lead to over-drainage if theresistance is low. For example, a common problem, which arises shortlyafter implantation, is hypotony, which occurs when IOP drops belowacceptable physiological levels (i.e., IOP<6 mmHg). Hypotony usuallytakes place the first few days to weeks following the implantation of aglaucoma drainage device, and is a combined result of a low fluidicresistance of both the implant and the distal outflow paths. Hypotonymay lead to a number of undesirable effects and complications, such ashypotensive maculopathy, cataract formation and optic nerve edema.Another problem, also related to the fixed fluid resistance ofpreviously known implants, is fibrosis, which appears progressively atlong term and which, depending on its extent and severity, may raise theeffective fluidic resistance of the implant, thereby raising the IOP todifferent, often non-physiological, levels.

The foregoing drawbacks have been recognized in the prior art, andseveral improvements have been attempted to improve flow control overthe entirely passive system described in Molteno.

For example, U.S. Pat. No. 5,411,473 to Ahmed describes a drainagedevice that includes a membrane-type valve. More specifically, Ahmeddescribes a drainage system including a membrane folded and held intension between two plates to provide a slit opening, such that themembrane responds to pressure changes to open or close the slit opening.Unfortunately, the operational characteristics of the system depend onthe properties of the membrane, which cannot be changed easily once thedevice is implanted. Also, the valve of Ahmed does not provide a trueopening pressure to accurately control post-operation IOP.

U.S. Pat. No. 6,544,208 to Ethier describes a self-regulating pressuresystem. More specifically, Ethier describes an implantable shunt devicehaving a flexible tube positioned in a pressurized enclosure. In thispatent, flow through the tube is dependent on a differential pressurebetween a pressure in the flexible tube and a pressure outside theflexible tube in the pressurized enclosure. However, one skilled andexperienced in the field of medical implants, especially inophthalmology, would understand that such a system with a constantexternal pressure chamber would be very impractical, if not impossible,to make.

Ethier further describes that the pressure outside the flexible tube inthe pressurized enclosure of the implantable shunt device is generatedby osmotic effects. More specifically, the pressurized enclosure isfilled with a solution containing a solute that generates an osmoticpressure which controls the opening pressure of the implantable shuntdevice. The implantable shunt device includes a semi-permeable membraneaffixed between support gratings that reduce deformation of thesemi-permeable membrane. Unfortunately, significant deformation of thesemi-permeable membrane makes it difficult to predict the osmoticpressure within the pressurized enclosure.

U.S. Pat. No. 9,101,445 to Bigler describes an ocular drainage systemfor treating diseases that produce elevated intraocular pressures, suchas glaucoma, wherein the system includes an implantable device and anexternal control unit. The implantable device includes a non-invasivelyadjustable valve featuring at least one deformable tube and a diskrotatably mounted within a housing, such that rotation of the disk usingthe external control unit causes the disk to apply a selected amount ofcompression to the deformable tube, thereby adjusting the fluidicresistance of the deformable tube and regulating the intraocularpressure.

Still other examples of previously-known systems are known. U.S. Pat.Nos. 5,626,558 and 6,508,779 to Suson describe a shunt which may beadjusted after implantation by using a low power laser to drilladditional openings in the tube wall to adjust the flow rate. U.S. Pat.No. 6,186,974 to Allan et al. describes a drainage shunt having multiplelayers, one of which may be a gel that swells upon absorption of fluidto adjust flow rate through the tube. U.S. Pat. No. 6,726,664 to Yarondescribes a drainage tube including a distal hook that retains thedistal end of the implant within the anterior chamber of the eye, andvarious means, such as rods or sutures, for partially occluding thelumen of the tube to regulate flow.

Other previously-known glaucoma treatment systems include significantlygreater complexity to address the drawbacks of the simpler shunt systemsdescribed above. For example, U.S. Pat. No. 6,077,299 to Adelberg, etal. describes a non-invasively adjustable valve implant for the drainageof aqueous humor for treatment of glaucoma, wherein an implant having aninlet tube is surgically inserted in the anterior chamber of the eye toallow aqueous humor to flow from the anterior chamber to a valve. Afterpassing through a pressure and/or flow regulating valve in the implant,the fluid is dispersed along the periphery of the implant to theinterior of the Tenon's capsule where it is absorbed by the body. In oneembodiment, the valve inhibits flow below, and allows flow above, aspecific pressure difference between the IOP within the eye and thepressure within the bleb cavity in the Tenon's capsule. The specifiedpressure difference or set-point is always positive and the valve isalways closed in the presence of negative pressure differences, toprevent reverse flow of fluid from the Tenon's capsule back into theanterior chamber of the eye.

In Adelberg, the valve is formed by a chamber to which the inlet tube isconnected, such that the chamber is closed by a pressure sensitive valvein the shape of a flat cone. The pressure regulation set point of thevalve is governed by a flexible diaphragm that cooperates with anarmature plate having an inclined surface, and which is configured toslide over a complementary inclined surface attached to the diaphragm.Cooperation of the inclined surface of the plate and the complementarysurface causes the diaphragm to deflect depending on where the armatureplate is located. The armature plate is rotated, using a rotor and a setof speed-reducing and torque-enhancing gears, to regulate the flowthrough the device. The characteristics of the valve strongly depend onthe configuration of the cone shaped valve. In addition, the regulatingmechanism is complex, including many rotating parts and gears, and thiscomplexity poses a risk of malfunction.

In view of the drawbacks of the foregoing prior art devices and methods,it would be desirable to provide an ocular drainage system and methodsthat are capable of maintaining a constant, or nearly constant, IOP.

It further would be desirable to provide an ocular drainage systemeffective to prevent hypotony post-implantation and/or effective inlight of the development of fibrosis at long term.

It further would be desirable to provide an ocular drainage systemhaving few moving parts, thereby enhancing robustness of the system andreducing the risk of failure arising from operation of complexmechanisms.

It further would be desirable to provide an ocular drainage systemhaving a small volume to facilitate implantation of the device beneaththe conjunctiva, either under a relatively small scleral flap or on thescleral surface, or even within a diffuser plate.

Finally, it would be desirable to provide an ocular drainage systemwherein moving parts of the system are configured to reduce the risk ofclogging or seizing due to the buildup of proteinaceous sediments.

SUMMARY

The present invention overcomes the drawbacks of previously-known oculardrainage systems by providing an implantable device for the treatment ofexcess fluid pressure within an eye as described herein. The deviceincludes a housing shell sized and shaped to be implanted beneath theconjunctiva, e.g., under a scleral flap. The housing shell has a firstend sized and shaped for fluid communication with an anterior chamber ofthe eye, a second end sized and shaped for fluid communication with aspace beneath tissue of the eye, e.g., a space beneath the conjunctivaor a rear space of the eye such as an orbital fat space of the eye, anddefining a cavity between the first end and the second end. Accordingly,the second end of the housing shell permits drainage into the spacebeneath the conjunctiva or the rear space of the eye.

The device further includes an elastic membrane disposed within thecavity to divide the cavity into a fluidic channel that permits a flowof fluid from the first end to the second end and a sealed cavity. Theelastic membrane is constructed to deform to change the volume of thesealed cavity responsive to pressure fluctuations between the first andsecond ends, thereby varying the fluidic resistance of the flow of fluidthrough the fluidic channel. The elasticity of the elastic membrane isselected to establish a balance between an external pressure at thesecond end and an internal pressure of the eye at the first end. Thefluidic channel preferably has a rectangular-shaped cross-section.

The housing shell may have a radius of curvature selected to accommodatea radius of curvature of the eye, and may be formed of a biocompatiblematerial. The outer surface of the housing shell may have a cylindricalshape. In accordance with one aspect of the present invention, thehousing shell is sized and shaped to be implanted above a sclera.Accordingly, a protective patch may be positioned above the housingshell to protect a conjunctival layer from device-induced erosion.

Further, the first end of the housing shell includes an inlet connector,and the second end of the housing shell includes an outlet connector.The device further may include a nozzle having an outlet end coupled tothe inlet connector, and an inlet end sized and shaped to pass through awall of the eye to communicate with the anterior chamber of the eye. Inaddition, the device may include a draining tube having a proximal endcoupled to the outlet connector, and a distal region sized and shaped tobe disposed within the space beneath the tissue of the eye. For example,the distal region of the drainage tube may include one or more drainageholes. Accordingly, the space may be an orbital fat space such that theone or more drainage holes permit drainage into the orbital fat space.

In accordance with another aspect of the present invention, the deviceincludes a diffuser plate, e.g., a Seton tube, sized and shaped to bedisposed beneath the tissue of the eye, wherein the diffuser plate has agroove sized and shaped to receive a portion of the distal region of thedrainage tube. Alternatively, the diffuser plate may be directly coupledto the outlet connector of the implantable device, e.g., the housingshell may be disposed within the diffuser plate.

The device also may include a local constriction disposed within aportion of the cavity of the housing shell to reduce the area in thecavity that forms the fluidic channel to increase fluidic resistance ofthe flow of fluid through the fluidic channel. Accordingly, the localconstriction forms a lower surface of the fluidic channel, and theelastic membrane forms an upper surface of the fluidic channel.

In accordance with another aspect of the present invention, the cavityhas a circular-shaped cross-section. For example, the local constrictionmay be positioned along a central longitudinal axis of the cavity. Inthis embodiment, the elastic membrane is positioned around the localconstriction. In accordance with yet another aspect of the presentinvention, the local constriction may have one or more grooves disposedalong its outer surface.

BRIEF DESCRIPTION OF THE DRAWINGS

The above features and advantages of the present invention will beapparent upon consideration of the following detailed description, takenin conjunction with the accompanying drawings, in which like referencecharacters refer to like parts throughout, and in which:

FIG. 1A is a schematic diagram illustrating the geometry of an exemplarydevice for the treatment of excess fluid pressure within an eye inaccordance with the principles of the present invention.

FIG. 1B is a schematic diagram illustrating the device of FIG. 1A inresponse to a pressure differential between the inlet and outlet ends ofthe device.

FIG. 2 is graph showing upstream pressure (IOP) vs. downstream pressureof an exemplary device for the treatment of excess fluid pressure withinan eye constructed in accordance with the principles of the presentinvention.

FIG. 3A is a side sectional view of an exemplary device for thetreatment of excess fluid pressure within an eye constructed inaccordance with the principles of the present invention.

FIG. 3B is a perspective view of the exemplary device of FIG. 3A.

FIG. 4A illustrates the exemplary device of FIG. 3A coupled to a nozzleand a drainage tube in accordance with the principles of the presentinvention.

FIG. 4B illustrates the exemplary device of FIG. 3A coupled to a nozzleand a diffuser plate via a drainage tube in accordance with theprinciples of the present invention.

FIG. 5A is a cross-sectional view of another exemplary device for thetreatment of excess fluid pressure within an eye in accordance with theprinciples of the present invention.

FIG. 5B is a cross-sectional view illustrating the device of FIG. 5A inresponse to a pressure differential between the inlet and outlet ends ofthe device.

DETAILED DESCRIPTION

In accordance with the principles of the present invention, animplantable device is provided for treating excessive intraocularpressure within an eye. In a preferred embodiment, the implantabledevice includes a cavity and an elastic membrane disposed within thecavity, thereby creating a fluidic passageway through the device. Theelastic membrane is self-regulating to control the flow of aqueous humorfrom an anterior chamber of the eye, through the passageway, to a sinkoutside the eye (e.g., a bleb formed under a scleral flap or the orbitalfat space of the eye). In accordance with one aspect of the presentinvention, the implantable device includes an area of local constrictiondisposed within the cavity to reduce the area of the fluidic passagewayto increase fluidic resistance of the flow of fluid through thepassageway. In an alternative embodiment, the implantable deviceincludes a circular-shaped passageway such that the elastic membrane ispositioned around the local constriction along the longitudinal axis ofthe passageway. The elastic membrane has an elasticity that allows theimplantable device to maintain intraocular pressures within a desiredrange, thereby reducing the risk of damage to the optic nerve withoutrequiring re-operation.

The device of the present invention is expected to provide a number ofadvantages over the previously-known devices and methods, including:

-   -   self-regulating pressure within the device to adapt to pressure        changes either in the interior chamber of the eye, or distally        at the output;    -   limiting the increase of IOP as a result of an increase of        downstream pressure due to development of fibrosis;    -   limiting the decrease of IOP to avoid hypotony, especially        during the time period shortly following implantation of the        implantable device; and/or    -   a low volume design that facilitates implantation under a        relatively small scleral flap or simply on the scleral surface,        or even within a diffuser plate.

Referring now to FIGS. 1A and 1B, an exemplary device for the treatmentof excess intraocular pressure within an eye is described. Implantabledevice 100 includes housing shell 101 having upper portion 103, lowerportion 105, inlet end 102 and outlet end 104. Housing shell 101preferably has a cylindrically-shaped outer surface, and comprises abiocompatible, waterproof or water-resistant plastic such as polyetherether ketone (“PEEK”), polycarbonate or titanium. The use of PEEK orsimilar polymer is particularly desirable, as such polymers provide goodbiocompatibility and long-term structural stability when implanted.Upper portion 103 and lower portion 105 may be separate pieces andmolded together during manufacturing of device 100, or alternatively,upper portion 103 and lower portion 105 may be formed as a single piece.

Implantable device 100 is configured to be implanted within the eye,e.g., under the conjuctiva, which may be formed using techniques ascommonly known in the field of glaucoma filtration surgery. The humaneye is generally spherical, having a radius of curvature ofapproximately 11 mm. While implantable device 100 may be fabricated as acylindrical device, advantageously housing shell 101 may include aconcave recess on the exterior of lower portion 105 and convex shape onthe exterior of upper portion 103, each having a curvature thatapproximates that of the human eye so that implantable device 100 willlie snugly against the exterior of the eye beneath a scleral flap.Preferably, the radius of curvature R of lower portion 105 of housingshell 101 is in a range of about 10 mm to about 12 mm, and morepreferably about 11 mm.

In addition, housing shell 101 has cavity 107 there, which may extendthrough housing shell 101 to permit fluid flow from inlet end 102 tooutlet end 104. Cavity 107 may have a circular cross-section withinhousing shell 101. In accordance within another aspect of the presentinvention, cavity 107 may have a rectangular cross-section withinhousing shell 101. As shown in FIGS. 1A and 1B, device 100 includeselastic membrane 110 disposed within cavity 107 having a first endcoupled to inlet end 102 and a second end coupled to outlet end 104,thereby diving cavity 107 into sealed cavity 112 between an innersurface of upper portion 103 of housing 101, and fluidic channel 106between elastic membrane 110 and lower portion 105 of housing 101.Sealed cavity 112 is filled with a compressible gas, e.g., air, and isleak-proof. Elastic membrane 110 preferably is constructed of a flexiblebiocompatible material that requires predetermined level of force todeform within sealed cavity 112 to change the volume of sealed cavity112 responsive to pressure fluctuations across inlet end 102 and outletend 104.

Local constriction 108 may be positioned within cavity 107 adjacentlower portion 105 of housing 100, thereby reducing the area in cavity107 that forms fluidic channel 106 to increase fluidic resistance of theflow of fluid through fluidic channel 106. As will be understood by aperson ordinarily skilled in the art, local constriction 108 and lowerportion 105 of housing shell 101 may be separate pieces and moldedtogether during manufacturing of device 100, or alternatively, localconstriction 108 and lower portion 105 may be formed as a single piece.

As illustrated in FIGS. 1A and 1B, cavity 107 of housing shell 101 mayhave an inlet passageway adjacent inlet end 102 and an outlet passagewayadjacent outlet end 104, both having a height and/or width consistentwith that of fluidic channel 106 formed by local restriction 108 and/orelastic membrane 110. Advantageously, aqueous humor drained from the eyeflows only through the interior of fluidic channel 106, while elasticmembrane 110 separates fluidic channel 106 from sealed cavity 112.Sealed cavity 112 is leak-proof which ensures that fluid such as, e.g.,aqueous humor, or proteinaceous materials contained within the aqueoushumor, traveling through fluidic channel 106 does not enter sealedcavity 112, and thus will not fill, clog or block sealed cavity 112,thereby reducing the risk of component failure.

Device 100 also includes inlet connector 114 coupled to inlet end 102,such that inlet connector 114 is in fluid communication with fluidicchannel 106, and outlet connector 116 coupled to outlet end 104, suchthat outlet connector 116 is in fluid communication with fluidic channel106. Inlet connector 114 and outlet connector 116 allows device 100 tobe coupled to additional drainage tubes such that fluid passing frominlet end 102 to outlet end 104 may be deposited with a bleb formed inthe sclera of the patient's eye. For example, aqueous humor from theanterior chamber of the eye enters device 100 via inlet connector 114,passes through fluidic channel 106 and outlet connector 116 to theexterior of the eye, typically inside a cavity formed by the scleralflap cavity. In accordance with the principles of the present invention,the rate of drainage, and consequently, the IOP, depends on the fluidicresistance of fluidic channel 106 based on the elasticity of elasticmembrane 110.

FIG. 1A depicts expected operation of implantable device 100 at regularIOP levels, e.g., when the downstream external pressure is very low (<3mmHg). As illustrated in FIG. 1A, elastic membrane 110 and localconstriction 108 define fluidic channel 106 within cavity 107 of housingshell 101 having a flow area and a corresponding fluidic resistance whenelastic membrane 110 is in its undeformed state. In this case, thebalance of forces between the pressure applied against elastic membrane110 from within sealed cavity 112 and the pressure forces within fluidicchannel 106 as a result of the flow of aqueous humor from the anteriorchamber of the eye from inlet end 102, through fluidic channel 106, andto a sink outside the eye via outlet end 104, define the geometry ofelastic membrane 110, the cross-sectional area of fluidic channel 106,and therefore its hydraulic resistance. In this case, implantable device100 will maintain a near-constant desired IOP at physiological levels atinlet end 102 even if flow or pressure at outlet end 104 changes.

Fluid flow from inlet end 102 to outlet end 104 within fluidic channel106 applies pressure to the interior surface of elastic membrane 110. Ifthe internal pressure within fluidic channel 106 increases beyond apredetermined amount, elastic membrane 110 will “bulge” out, e.g.,deform into sealed cavity 112 as shown in FIG. 1B, thereby decreasingthe hydraulic resistance of fluidic channel 106.

Here, a simple viscous resistance law is applied:

${\frac{P_{in} - P_{out}}{R} = Q};$

Therefore, P_(in)=P_(out) ^(+R*Q)

As downstream external pressure (P_(out)) increases, the pressure withinfluidic channel 106 will initially increase as it is always boundedbetween upstream intraocular pressure (P_(in)) at inlet end 102 todownstream external pressure (P_(out)) at outlet end 104. Thus, elasticmembrane 110 will “bulge” into sealed cavity 112. This will increase thecross-sectional area and overall volume of fluidic channel 106, and thuslower hydraulic resistance (R) to a level such that P_(in) will beeffectively unchanged.

FIG. 1B illustrates expected operation of implantable device 100 whenthere is, for example, an increase in IOP levels at inlet end 18. Forexample, if flow increases, IOP will increase and the average pressureforces within fluidic channel 106 will increase, which will causeelastic membrane 110 to bulge, e.g., deform into sealed cavity 112,resulting in a larger flow area, smaller fluidic resistance andconsequently a decrease in IOP, thereby allowing the IOP to bemaintained at a pre-determined desired level. Any scenario causing IOPto increase will result in deformable structure equilibrating at a new,larger flow area and increased flow that will result in turn reduce IOP.As illustrated in FIG. 1B, the expansion of elastic membrane 110 has aparabolic shape along elastic membrane 101, such that fluidic channel106 has the largest cross-sectional area adjacent the center of elasticmembrane 110, and reduces in size toward inlet end 102 and outlet end104 where elastic membrane 110 is fixed to housing shell 101.

Similarly, if pressure at outlet end 104 increases, for example, due tothe development of fibrosis at outlet end 20, the average pressurewithin fluidic channel 106 will increase, causing elastic membrane 110to deform into sealed cavity 112, which in turn will result in increasedflow area and smaller fluidic resistance within fluidic channel 106.Consequently, the increase of IOP at inlet end 102 will be limited.

In accordance with one aspect of the present invention, if IOP at inletend 102 decreases, for example, during the period of time right afterimplantation which may cause hypotony, the average pressure withinfluidic channel 106 will decrease, which may cause elastic membrane 110to deform toward fluidic channel 106, thereby increasing the volume ofsealed cavity 112 and resulting in a smaller flow area and largerfluidic resistance within fluidic channel 106. This in turn will limitthe decrease of IOP at inlet end 102 and reduce the risk of hypotony.

For a given flow through fluidic channel 106, device 100 becomes anupstream pressure regulator in the sense that, if fluidic pressurewithin fluidic channel 106 increases, elastic membrane 110 will deforminto sealed cavity 112 and the hydraulic resistance will decrease. Inthis case, the pressure at inlet end 102 is maintained relativelyconstant as illustrated in FIG. 2. FIG. 2 is a graph depicting upstreampressure at the inlet end of the device, i.e., internal intraocularpressure within the eye, versus downstream pressure at the outlet end ofthe device, external pressure, from an vitro test on a 1:1 scaleprototype of device 100. As shown in FIG. 2, when downstream pressurevaries from 0 to 15 mmHg, upstream pressure is maintained relativelyconstant, e.g., around 15 mmHg.

Referring now to FIGS. 3A and 3B, an exemplary embodiment of the devicefor the treatment of excess fluid pressure within an eye constructed inaccordance with the principles of the present invention is described. Asshown in FIGS. 3A and 3B, housing 101 has a cylindrically-shaped outersurface. Inlet connector 114 and outlet connector 116 are sized andshaped to be coupled with additional drainage tubes such that fluidicchannel 106 may be in fluidic communication with the anterior chamber ofthe eye as well as a space, e.g., orbital fat space, of the eye. Forexample, the outer surface of inlet connector 114 and outlet connector116 may have ridges for a fluid-tight connection with the additionaldrainage tubes such that external bodily fluids may not enter the lumenof inlet connector 114 and outlet connector 116, and consequentlyfluidic channel 106. As illustrated in FIG. 3A, the lumens of inletconnector 114 and outlet connector 116 may have a circularcross-sectional area. Aqueous humor enters fluidic channel 106 via thelumen of inlet connector 114 and a narrow passageway at inlet end 102,and exits device 100 via a narrow passageway at outlet end 104 and thelumen of outlet connector 116.

Referring now to FIGS. 4A and 4B, device 100 may be coupled to variousdrainage tubes for treatment of excess fluid pressure within a patient'seye. For example, as illustrated in FIG. 4A, device 100 may be coupledto nozzle 118 via inlet connector 114. Nozzle 118 has proximal end 120,distal end 122, and a lumen extending therebetween sized and shaped forflow of aqueous humor from proximal end 120 to distal end 122. Distalend 122 may be removably coupled to inlet connector 114 of implantabledevice 100, e.g., after implantation of nozzle 118 and afterimplantation of implantable device 100. Nozzle 118 is designed to extendfrom inlet connector 114 and be disposed through the wall of the eye andinto the anterior chamber. For example, proximal end 120 of nozzle 118is sized and shaped to extend through the wall of the eye and into theanterior chamber when device 100 is implanted beneath a flap formed in apatient's sclera. To facilitate the introduction of nozzle 118 into theanterior chamber of the eye, proximal end 120 of nozzle 118 may have aconical or sharpened extremity that facilitates piercing of the scleraltissue and introduction of the nozzle into the anterior chamber. Distalend 122 is sized and shaped to receive inlet connector 114 of device 100in a fluid-tight manner such that external bodily fluids cannot enterhousing shell 101. Accordingly, the lumen of nozzle 118 is in fluidcommunication with fluidic channel 106 of device 100 via the lumen ofinlet connector 114.

In addition, device 100 may be coupled to drainage tube 124. Drainagetube 124 has proximal end 126, distal region 128, and a lumen extendingtherebetween sized and shaped for flow of aqueous humor from proximalend 126 to distal end 128. Proximal end 126 may be removably coupled tooutlet connector 116 of implantable device 100, e.g., after implantationof drainage tube 124 and after implantation of implantable device 100.Drainage tube 124 preferably has a length such that it extends fromoutlet connector 116 and distal region 128 is disposed within a spacebeneath tissue of the eye, e.g., a space beneath the conjunctiva or anorbital fat space of the eye, for drainage of aqueous humor therein.Distal region 128 may include one or more drainage holes such that thelumen of drainage tube 128 may be in fluid communication with theorbital fat space of the eye. Drainage tube 128 may be made of, forexample, silicone, and may be sufficiently flexible to accommodate thecurvature of the patient's eye.

Flow exiting through drainage tube 128 is deposited within the sclera,where it drains primarily to the connecting vein network. Alternatively,a surgeon may make a second scleral flap with a large cavity beneath it(a bleb) and then form a channel to connect the scleral cavity holdingthe implantable device to the second cavity. In this case, aqueous humorexiting drainage tube 128 will flow via the channel to the secondcavity, where it will be absorbed. Alternatively, flow exiting throughdrainage tube 128 drains directly to the suprachoroidal space betweenthe sclera and the choroid of the eye.

Referring now to FIG. 4B, device 100 may be coupled to nozzle 118 viainlet connector 114 as described above, and further coupled to diffuserplate 130, e.g., a Seton tube, via outlet connector 116 and drainagetube 124. For example, distal region 128 of drainage tube 124 may becoupled to diffuser plate 130. Flow exiting through outlet connector 116travels through drainage tube 124 into diffuser plate 130 and isultimately deposited within the sclera, where it drains primarily to theconnecting vein network. Specifically, drainage tube 124 coupled todiffuser plate 130 may be positioned so that diffuser plate 130 isdisposed on the surface of the eye such that aqueous humor may beabsorbed into the scleral tissue, e.g., into the connecting veinnetwork, and distal region 128 of drainage tube 124 is disposed in aspace, e.g., the orbital fat space, of the eye, such that aqueous humormay be absorbed into the orbital fat space of the eye. Diffuser plate130 may be curved to accommodate the curvature of the eye and mayinclude eyelets 132 shaped and sized to permit diffuser plate 130 to beimplanted and remain in position once implanted on an exterior surfaceof the eye via, e.g., sutures. In this embodiment, diffuser plate 130may include one or more drainage holes along its upper surface such thatthe lumen of drainage tube 124 may be in communication with the uppersurface of diffuser plate 130.

Diffuser plate 130 may be positioned along drainage tube 125 in betweenproximal end 126 and the one or more drainage holes disposed alongdistal region 128 of drainage tube 124. For example, diffuser plate 130may include a groove shaped and sized to receive drainage tube 124, anddrainage tube 124 may be maintained within the groove via, e.g.,friction or an adhesive. In this embodiment, the one or more drainageholes along distal end 128 of drainage tube 124 in proximity to thegroove allows aqueous humor within the lumen of drainage tube 124 to bein communication with the upper surface of diffuser plate 130.Accordingly, when proximal end 126 of drainage tube 124 is coupled tooutlet connecter 116 of implantable device 100, aqueous humor that exitsoutlet connecter 116 of implantable device 100 may exit via the one ormore drainage holes and drain over the upper surface of diffuser plate130 into the scleral tissue, and/or exit via the one or more drainageholes at distal region 128 of drainage tube 124 into the orbital fatspace. In this case, overall resistance of aqueous humor throughdrainage tube 124, e.g., due to tissue growth at either the one or moredrainage holes, may be maintained within a desired limit.

In accordance with another aspect of the present invention, implantabledevice 100 is designed to be implanted within the diffuser plate on thescleral surface of a human eye. In this embodiment, the nozzle is sizedand shaped to extend from within the diffuser plate along the curvatureof the eye and to be disposed through the wall of the eye and into theanterior chamber. Flow enters the implantable device through the nozzlecoupled to the inlet connector of the device and exits through theoutlet connector into the diffuser plate and is ultimately depositedbeneath the tissue of the eye, where it drains primarily to theconnecting vein network.

In accordance with one aspect of the present invention, implantabledevice 100 may be implanted beneath the conjunctiva, on the scleralsurface of the eye. In this embodiment, a protective patch, e.g., alayer of allograft tissue, may be positioned above the implantabledevice to protect the adjacent conjunctival layer from device-inducederosion.

Referring now to FIGS. 5A and 5B, an alternative exemplary embodiment ofthe device for the treatment of excess fluid pressure within an eyeconstructed in accordance with the principles of the present inventionis described. Device 200 is based on the same principles as device 100described above, such that increased pressure within the fluidic channelof device 200 causes an elastic membrane to “bulge,” thereby enlargingthe flow area and reducing hydraulic resistance within the fluidicchannel. Housing shell 201 has a cylindrical-shaped outer surface, andinlet end and an outlet end, and defining cavity 204 between the inletend and the outlet end. Device 200 differs from device 100 in that localconstriction 202 has a circular cross-section and is positioned alongthe longitudinal axis of cavity 204 of cylindrical-shaped housing shell201. As shown in FIGS. 5A and 5B, local constriction 202 includes one ormore grooves along its outer surface, thereby creating one or morerespective fluidic channels 206. As will be understood by a personhaving ordinary skill in the art, local constriction 202 may have feweror more than four grooves, and accordingly, device 200 may have few ormore than four fluidic channels.

Aqueous humor flows from the inlet end of device 200, through the one ormore fluidic channels 206, and out the outlet end of device 200. Inaddition, device 200 includes elastic membrane 208 positionedcircumferentially around local constriction 202 within cavity 204,thereby dividing cavity 204 into sealed cavity 210 between an innersurface of housing shell 201 and elastic membrane 208, and one or morefluidic channels 206 between the grooves of local constriction 202 andelastic membrane 208. Elastic membrane 208 is fixed at one end to theinlet end of device 200, and at the opposite end to the outlet end ofdevice 200. Therefore, as pressure within one or more fluidic channels206 increase, elastic membrane 208 “bulges” toward sealed cavity 210 inthe direction of the arrows as shown in FIG. 5B, which causes the flowarea of the one or more fluidic channels 206 to increase, therebydecreasing hydraulic resistance through one or more fluidic channels206.

Methods of implanting and using an implantable device constructed inaccordance with the principles of the present invention are nowprovided. An implantable device (e.g., device 100 or 200) may beimplanted using a surgical technique similar to that used for prior artglaucoma drainage devices. As will be understood, for device 100 of theembodiment of FIG. 3A, a scleral flap is created in a manner analogousto standard trabeculectomy, and the flap is dissected carefully up toclear cornea. The scleral flap is lifted and care is taken to identifythe center of the “blue zone” adjacent to clear cornea, whichcorresponds to the location of the trabecular meshwork. As will beunderstood by one of skill in the art, the “blue zone” generally islocated posterior to the anterior limbal border, and terminates inmidlimbal line. A 26-gauge needle is inserted into the anterior chamberthrough the center of the “blue zone” at an angle parallel to the planeof the iris. Next, the nozzle of the implantable device is inserted intothe anterior chamber through the ostium created by the needle until thehousing lies flush against the eye. The scleral flap then is sutured inplace, e.g., using a 10-0 nylon suture with a spatulated needle. Finallythe conjunctiva is carefully sutured closed to complete the implantationprocess.

Alternatively, a small incision is made in the conjunctiva as an openingfor the implantable device. The implantable device is positioned on thesclera surface such that the opening of the nozzle is disposed through awall of the eye in the anterior chamber of the eye, within the aqueoushumor. The implantable device then may be connected to a Seton tubecoupled to a diffuser plate above the sclera of the eye, a drainagetube, or a drainage tube coupled to a diffuser plate above the sclera ofthe eye. Optionally, a layer of allograft tissue may be sutured in placeover the implantable device to reduce the risk of erosion of theadjacent conjunctival layer. Finally the conjunctiva is carefullysutured closed to complete the implantation process.

Alternative embodiments of the ocular drainage system of the presentinvention may include a miniaturized pressure sensor disposed with theimplantable device and in communication with the inlet conduit tomeasure IOP. This sensor may be coupled to a miniaturized telemetrysystem, such as those based on radio frequency identification principlesthat may be energized from a distance, to emit a signal that can bereceived and interpreted by an external receiver. This arrangement wouldprovide a ready way in which to non-invasively determine IOP.

While various illustrative embodiments of the invention are describedabove, it will be apparent to one skilled in the art that variouschanges and modifications may be made therein without departing from theinvention. The appended claims are intended to cover all such changesand modifications that fall within the true spirit and scope of theinvention.

What is claimed is:
 1. A device for the treatment of excess fluidpressure within an eye, the device comprising: a housing shellconfigured to be implanted beneath a conjunctiva, the housing shellhaving a first end configured for fluid communication with an anteriorchamber of the eye, a second end configured for fluid communication witha space beneath tissue of the eye, and defining a cavity between thefirst end and the second end; an elastic membrane disposed within thecavity to divide the cavity into a fluidic channel that permits a flowof fluid from the first end to the second end and a sealed cavity, theelastic membrane configured to deform to change the volume of the sealedcavity responsive to pressure fluctuations between the first and secondends, thereby varying the fluidic resistance of the flow of fluidthrough the fluidic channel.
 2. The device of claim 1, wherein thehousing shell has a radius of curvature selected to accommodate a radiusof curvature of the eye.
 3. The device of claim 1, wherein the housingshell comprises biocompatible material.
 4. The device of claim 1,wherein the housing shell is configured to be implanted under a scleralflap.
 5. The device of claim 1, wherein an outer surface of the housingshell comprises a cylindrical shape.
 6. The device of claim 1, whereinthe housing shell is configured to be implanted above a sclera, thedevice further comprising a protective patch configured to protect aconjunctival layer from device-induced erosion, wherein the protectivepatch is positioned above the housing shell.
 7. The device of claim 1,wherein the first end of the housing shell comprises an inlet connector,and the second end of the housing shell comprises an outlet connector.8. The device of claim 7, further comprising a nozzle having an outletend coupled to the inlet connector, and an inlet end configured to passthrough a wall of the eye to communicate with the anterior chamber ofthe eye.
 9. The device of claim 7, further comprising a draining tubehaving a proximal end coupled to the outlet connector, and a distalregion configured to be disposed within the space beneath the tissue ofthe eye.
 10. The device of claim 9, wherein the distal region of thedrainage tube comprises one or more drainage holes.
 11. The device ofclaim 9, further comprising a diffuser plate having a groove configuredto receive a portion of the distal region of the drainage tube, thediffuser plate configured to be disposed beneath the tissue of the eye.12. The device of claim 11, wherein the diffuser plate is a Seton tube.13. The device of claim 7, further comprising a diffuser plate coupledto the outlet connector, the diffuser plate configured to be disposedbeneath the tissue of the eye.
 14. The device of claim 13, wherein thehousing shell is disposed within the diffuser plate.
 15. The device ofclaim 1, wherein the space beneath the tissue of the eye is the spacebeneath the conjunctiva or a rear space of the eye such as an orbitalfat space, such that the second end of the housing shell permitsdrainage into the space beneath the conjunctiva or the rear space of theeye.
 16. The device of claim 1, wherein the fluidic channel has arectangular-shaped cross-section.
 17. The device of claim 1, furthercomprising a local constriction disposed within a portion of the cavityof the housing shell to reduce the area in the cavity that forms thefluidic channel to increase fluidic resistance of the flow of fluidthrough the fluidic channel, wherein the local constriction forms alower surface of the fluidic channel, and wherein the elastic membraneforms an upper surface of the fluidic channel.
 18. The device of claim17, wherein the cavity has a circular-shaped cross-section, wherein thelocal constriction is positioned along a central longitudinal axis ofthe cavity, and wherein the elastic membrane is positioned around thelocal constriction.
 19. The device of claim 17, wherein the localconstriction comprises one or more grooves disposed along an outersurface of the local constriction.
 20. The device of claim 1, wherein anelasticity of the elastic membrane is selected to establish a balancebetween an external pressure at the second end and an internal pressureof the eye at the first end.